Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination

Criteria

Inclusion Criteria:

• age 20 ~ 75 inclusive

• Asthmatic diagnosis in more than 12 weeks from screening day

• Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2

Exclusion Criteria:

• Maintain controlled asthma for more than 4 weeks before screening

• Diagnosed as a severe asthmatic patients